Changes in air pressure during a flight can cause insulin pumps to unintentionally deliver too much insulin during ascent or too little during descent. This could explain why episodes of hypoglycemia have been repeatedly observed in pump users after air travel. To date, this has only been studied in adults using AID systems under real-world flight conditions—it is unclear whether the positive results can be extrapolated to children and adolescents due to their different physiology and daily habits. This study compares the safety and efficacy of automated insulin delivery (AID) systems and sensor-augmented pump (SAP) systems in children and adolescents with type 1 diabetes during air travel. Participants who have a scheduled flight during the 12-month study period will first document only their meal times for 14 days prior to the flight while following their normal diabetes management routine. This data collection will continue on the day of the flight, during the flight, and 24 hours after landing—and will be repeated for the return flight. The primary objective is to determine how much time participants spend within the target glucose range (3.9–10.0 mmol/l or 70–180 mg/dl), as measured by their usual continuous glucose monitoring system (e.g., Medtronic, Dexcom).
- Male or female participant aged 2 to 17 years old at time of study enrollment. - Participant’s parent/legal guardian must be willing and able to provide written signed and dated informed consent. - Participant must be willing and able to provide written signed and dated informed assent. - Diagnosed with T1D for at least 12 months. - Being treated with AID system or SAP therapy. - Citizen of an EU country or Switzerland/Norway/Iceland/United Kingdom speaking either English, German, Dutch, French, or Italian.
- Treatment in the prospective period of interest with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator.
Time in range (TIR) 3.9–10.0 mmol/l [70–180mg/dl] assessed via CGM during in-flight vs. a 14-day period of on-ground conditions (fasting and non-fasting conditions combined and separately).